MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 50MM

Model Number 25001050E

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The male-female midsection component was revised during a revision surgery.The sales representative stated that the patient pulled out the surgical drain after the prior surgery.He reported that this led to a revision surgery where the male-female midsection was revised.He stated that there was no failure of the male-female midsection component.No other information is available at this time.If more information is obtained, a supplement report will be submitted, multiple mdrs were submitted for this event: 3013450937-2021-00084, 3013450937-2021-00085, 3013450937-2021-00086, 3013450937-2021-00088, 3013450937-2021-00089, 3013450937-2021-00090, 3013450937-2021-00091.

Event Description

The patient involved in this complaint underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6).It was reported by the sales representative that the patient pulled out their surgical drain when the drain was supposed to remain in the patient according to post-operative instructions.The drain was placed on (b)(6) 2021 during a surgery performed by dr.(b)(6) to place eleos components for an unknown reason.During the revision surgery, the patient had eleos components explanted and replaced.There was no reported failure of the eleos components.It is unknown at this time why the components were replaced.No further information is available at this time.

Manufacturer Narrative

The root cause for the patient's tibial hinge component dislocating was unable to be definitively determined.The surgeon did lengthen the patient's segments in order to mitigate the risk of another dislocation occurring.It is unknown why the patient pulled out their surgical drain leading to the surgical incision to reopen.It is not known if these two events are related.However, the manufacturing and sterilization dhrs were reviewed as well as previous complaints and nonconformances, and there was no indication that this complaint was the result of a nonconformance.No trends were identified that show that this failure exceeded the risk acceptability provided in onkos risk management documentation.Mulitple mdrs were submitted for this event: 3013450937-2021-00084, 3013450937-2021-00085, 3013450937-2021-00086, 3013450937-2021-00088, 3013450937-2021-00089, 3013450937-2021-00090, 3013450937-2021-00091.

Event Description

A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to the patient's tibial hinge component dislocating.The patient also pulled out their surgical drain which reopened the surgical incision.It is unknown if the patient exerted themselves or sustained a trauma which may have contributed to the dislocation.It is unknown if the opening of the surgical incision contributed to the dislocation.During the revision, the distal femur (25000007e), the tibial hinge component (25002101e), the distal femur axial pin (25002111e), the femoral segmental stem (fs-20120-03m), and tibial poly spacer (25001208e) were placed.A new 50mm male-female midsection was placed to lengthen the limb to mitigate the risk of a dislocation occurring again.The tibial hinge component without rotational stop was replaced with a tibial hinge component with rotational stop.This was also done to mitigate risk of future dislocations.

• Brand Name: ELEOS
• Type of Device: MALE-FEMALE MIDSECTION, 50MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11866621
• MDR Text Key: 252137796
• Report Number: 3013450937-2021-00087
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001050E
• Device Catalogue Number: 25001050E
• Device Lot Number: 1873152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISTAL FEMUR AXIAL PIN- 25002111E; DISTAL FEMUR- 25000007E; SEGMENTAL STEM- FS-21120-03M; STEM EXTENSION- KSP17100E; TIBIAL BASEPLATE- 25002204E; TIBIAL HINE COMOPNENT- 25002101E; TIBIAL POLY SPACER- 25001208E
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR